FDA has approved Camptosar (irinotecan) for a new indication for first-line therapy in combination with 5-fluorouracil and leucovorin (5- FU/LV) to treat metastatic colorectal cancer. The following may be used to respond to questions.

It is estimated that about 130,000 people in the United States will be diagnosed with colorectal cancer this year. Primary treatment consists of surgery with or without adjuvant chemotherapy or radiation. About half the people treated this way will progress to metastatic disease (cancer that has spread outside of the colon or rectum). In these patients, 5-fluorouracil plus leucovorin (5FU/LV) in combination has been standard treatment. Camptosar was shown in two controlled studies to increase survival when it was added to 5-FU/LV in patients wit metastatic disease.

Approval of the new indication was based on two randomized, controlled, clinical trials in more than 800 patients comparing Camptosar in combination with 5-FU/LV to 5FU/LV without Camptosar. In the studies, the combination of Camptosar and 5FU/LV resulted in a significant delay in the time at which tumors progressed and significant improvement in survival compared with 5-FU/LV alone.

In one study, the median survival for patients on the regimen including Camptosar was 17.4 months for patients treated with Camptosar and 5-FU/LV administered by slow infusion compared to 14.1 months for patients treated with slow infusional 5-FU/LV alone. In the other study the median survival for patients treated with Camptosar plus a rapid infusion (bolus) of 5-FU/LV was 14.8 months compared to 12.6 months for patients treated with a different regimen of bolus 5-FU/LV alone.

Side effects of Camptosar include severe diarrhea (which can be prolonged and require supportive medical treatment), nausea, vomiting and neutropenia (drop in white blood cells).

On March 16, 2000, the FDA's Oncologic Drugs Advisory Committee unanimously recommended approval of the Camptosar plus 5-FU/LV regimen and agreed that this combination therapy is an important alternative for patients.

In 1996, Camptosar was granted accelerated approval for treatment of patients with metastatic carcinoma of the colon or rectum whose disease had recurred or progressed following 5-FU based therapy.

Accelerated approval is a regulatory mechanism that allows early approval of cancer drugs based on the effect on the tumor (shrinkage) rather than a clearly beneficial effect on the patient (better survival) on the condition that survival effects be studied. In l998, survival studies for Camptosar in refractory disease showed an effect on survival in patients whose cancer had recurred or progressed on 5FU.

Camptosar(administered by infusion) is manufactured by Pharmacia Corp of Peapak, New Jersey.